Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.

Kluge, Michael; Hegerl, Ulrich; Sander, Christian; Dietzel, Jens; Mergl, Roland; Bitter, Istvan; Demyttenaere, Koen; Gusmão, Ricardo; González-Pinto, Ana; Pérez Solà, Victor; Vieta i Pascual, Eduard, 1963-; Juckel, Georg; Zimmermann, Ulrich S.; Bauer, Michael; Sienaert, Pascal; Quintao, Sónia; Edel, Marc-Andreas; Bolyos, Csilla; Ayuso Mateos, José Luis; López García, Pilar

Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.

BACKGROUND: Treatment of patients with acute mania remains a considerable medical challenge since onset of action of antimanic medication is delayed for several days. Psychostimulants could have an earlier onset of action. This assumption is based on the 'vigilance regulation model of mania...

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Autores:	Kluge, Michael, Hegerl, Ulrich, Sander, Christian, Dietzel, Jens, Mergl, Roland, Bitter, Istvan, Demyttenaere, Koen, Gusmão, Ricardo, González-Pinto, Ana, Pérez Solà, Victor, Vieta i Pascual, Eduard, 1963-, Juckel, Georg, Zimmermann, Ulrich S., Bauer, Michael, Sienaert, Pascal, Quintao, Sónia, Edel, Marc-Andreas, Bolyos, Csilla, Ayuso Mateos, José Luis, López García, Pilar
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2013
País:	España
Institución:	Universidad de Barcelona
Repositorio:	Dipòsit Digital de la UB
OAI Identifier:	oai:diposit.ub.edu:2445/49503
Acceso en línea:	https://hdl.handle.net/2445/49503
Access Level:	acceso abierto
Palabra clave:	Trastorn bipolar Antidepressius Assaigs clínics de medicaments Manic-depressive illness Antidepressants Drug testing

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spelling	Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.Kluge, MichaelHegerl, UlrichSander, ChristianDietzel, JensMergl, RolandBitter, IstvanDemyttenaere, KoenGusmão, RicardoGonzález-Pinto, AnaPérez Solà, VictorVieta i Pascual, Eduard, 1963-Juckel, GeorgZimmermann, Ulrich S.Bauer, MichaelSienaert, PascalQuintao, SóniaEdel, Marc-AndreasBolyos, CsillaAyuso Mateos, José LuisLópez García, PilarTrastorn bipolarAntidepressiusAssaigs clínics de medicamentsManic-depressive illnessAntidepressantsDrug testingBACKGROUND: Treatment of patients with acute mania remains a considerable medical challenge since onset of action of antimanic medication is delayed for several days. Psychostimulants could have an earlier onset of action. This assumption is based on the 'vigilance regulation model of mania' which postulates that vigilance is unstable in manic patients. Accordingly, vigilance-stabilising psychostimulants could be more useful than conventional treatment in acute mania. We present here the study protocol of a trial intended to study the efficacy and safety of methylphenidate in the initial treatment of acute mania. METHODS/DESIGN: A multi-centre, randomised, double-blind, placebo-controlled clinical trial will be conducted in 88 bipolar inpatients with acute mania. Male and female patients older than 18 years will be randomised to treatment with either methylphenidate (20 to 40 mg/day) or placebo for 2.5 days, given once or twice daily. The main outcome measure is the reduction in the Young Mania Rating Scale (YMRS) after 2.5 days of treatment. Other outcome measures include the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) the Clinical Global Impression-Bipolar Scale (CGI-BP), the Screen for Cognitive Impairment in Psychiatry (SCIP), actigraphy and the EEG-'Vigilance Algorithm Leipzig' (VIGALL). DISCUSSION: A positive study outcome of the proposed study could substantially impact our understanding of the etiopathogenesis of mania and open new treatment perspectives.BioMed Central2013info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/49503Articles publicats en revistes (Psicologia Clínica i Psicobiologia)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: http://dx.doi.org/10.1186/1471-244X-13-71BMC Psychiatry, 2013, vol. 13, num. 13, p. 71http://dx.doi.org/10.1186/1471-244X-13-71cc-by (c) Kluge, M. et al., 2013http://creativecommons.org/licenses/by/3.0/esinfo:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/495032026-05-27T06:46:51Z
dc.title.none.fl_str_mv	Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.
title	Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.
spellingShingle	Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate. Kluge, Michael Trastorn bipolar Antidepressius Assaigs clínics de medicaments Manic-depressive illness Antidepressants Drug testing
title_short	Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.
title_full	Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.
title_fullStr	Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.
title_full_unstemmed	Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.
title_sort	Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.
dc.creator.none.fl_str_mv	Kluge, Michael Hegerl, Ulrich Sander, Christian Dietzel, Jens Mergl, Roland Bitter, Istvan Demyttenaere, Koen Gusmão, Ricardo González-Pinto, Ana Pérez Solà, Victor Vieta i Pascual, Eduard, 1963- Juckel, Georg Zimmermann, Ulrich S. Bauer, Michael Sienaert, Pascal Quintao, Sónia Edel, Marc-Andreas Bolyos, Csilla Ayuso Mateos, José Luis López García, Pilar
author	Kluge, Michael
author_facet	Kluge, Michael Hegerl, Ulrich Sander, Christian Dietzel, Jens Mergl, Roland Bitter, Istvan Demyttenaere, Koen Gusmão, Ricardo González-Pinto, Ana Pérez Solà, Victor Vieta i Pascual, Eduard, 1963- Juckel, Georg Zimmermann, Ulrich S. Bauer, Michael Sienaert, Pascal Quintao, Sónia Edel, Marc-Andreas Bolyos, Csilla Ayuso Mateos, José Luis López García, Pilar
author_role	author
author2	Hegerl, Ulrich Sander, Christian Dietzel, Jens Mergl, Roland Bitter, Istvan Demyttenaere, Koen Gusmão, Ricardo González-Pinto, Ana Pérez Solà, Victor Vieta i Pascual, Eduard, 1963- Juckel, Georg Zimmermann, Ulrich S. Bauer, Michael Sienaert, Pascal Quintao, Sónia Edel, Marc-Andreas Bolyos, Csilla Ayuso Mateos, José Luis López García, Pilar
author2_role	author author author author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	Trastorn bipolar Antidepressius Assaigs clínics de medicaments Manic-depressive illness Antidepressants Drug testing
topic	Trastorn bipolar Antidepressius Assaigs clínics de medicaments Manic-depressive illness Antidepressants Drug testing
description	BACKGROUND: Treatment of patients with acute mania remains a considerable medical challenge since onset of action of antimanic medication is delayed for several days. Psychostimulants could have an earlier onset of action. This assumption is based on the 'vigilance regulation model of mania' which postulates that vigilance is unstable in manic patients. Accordingly, vigilance-stabilising psychostimulants could be more useful than conventional treatment in acute mania. We present here the study protocol of a trial intended to study the efficacy and safety of methylphenidate in the initial treatment of acute mania. METHODS/DESIGN: A multi-centre, randomised, double-blind, placebo-controlled clinical trial will be conducted in 88 bipolar inpatients with acute mania. Male and female patients older than 18 years will be randomised to treatment with either methylphenidate (20 to 40 mg/day) or placebo for 2.5 days, given once or twice daily. The main outcome measure is the reduction in the Young Mania Rating Scale (YMRS) after 2.5 days of treatment. Other outcome measures include the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) the Clinical Global Impression-Bipolar Scale (CGI-BP), the Screen for Cognitive Impairment in Psychiatry (SCIP), actigraphy and the EEG-'Vigilance Algorithm Leipzig' (VIGALL). DISCUSSION: A positive study outcome of the proposed study could substantially impact our understanding of the etiopathogenesis of mania and open new treatment perspectives.
publishDate	2013
dc.date.none.fl_str_mv	2013
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	https://hdl.handle.net/2445/49503
url	https://hdl.handle.net/2445/49503
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.relation.none.fl_str_mv	Reproducció del document publicat a: http://dx.doi.org/10.1186/1471-244X-13-71 BMC Psychiatry, 2013, vol. 13, num. 13, p. 71 http://dx.doi.org/10.1186/1471-244X-13-71
dc.rights.none.fl_str_mv	cc-by (c) Kluge, M. et al., 2013 http://creativecommons.org/licenses/by/3.0/es info:eu-repo/semantics/openAccess
rights_invalid_str_mv	cc-by (c) Kluge, M. et al., 2013 http://creativecommons.org/licenses/by/3.0/es
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.publisher.none.fl_str_mv	BioMed Central
publisher.none.fl_str_mv	BioMed Central
dc.source.none.fl_str_mv	Articles publicats en revistes (Psicologia Clínica i Psicobiologia) reponame:Dipòsit Digital de la UB instname:Universidad de Barcelona
instname_str	Universidad de Barcelona
reponame_str	Dipòsit Digital de la UB
collection	Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate.

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